Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-02 @ 8:56 AM
Study NCT ID:
NCT00469404
Status:
TERMINATED
Last Update Posted:
2007-11-16
First Post:
2007-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)
Sponsor:
Grünenthal GmbH
Organization:
Study Overview
Official Title:
Single Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial end was achieved according to the definition in the trial protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the plasma levels of two different analgesic transdermal patch formulations lead to same plasma levels of the active ingredient after single dose application.
Detailed Description:
Main: To demonstrate the bioequivalence between the two transdermal analgesic formulations after single patch application. Pharmacokinetic target parameters are AUC, AUC0-t, and Cmax.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: